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临床试验/NCT03186157
NCT03186157终止不适用

A Prospective Observational Study on Risk Factors of Developing and Prevalence of Trephined Syndrome in Patients After Hemispheric Decompressive Craniectomy and Effect of Cranioplasty on Functional and Cognitive Recovery

University Hospital, Geneva1 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2012年1月16日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
41
试验地点
1
主要终点
Presence of Trephined Syndrome

研究概览

简要总结

Decompressive craniectomy is frequently used to treat increased intracranial pressure or an intracranial mass effect. Trephined Syndrome describes a neurological deterioration, which is attributed to a large craniectomy. The symptomatology is varied but includes headache, aggravation of a hemisyndrome or cognitive disorders, often has an orthostatic component and improves or disappears with cranioplasty. The incidence of Trephined Syndrome has been reported between 7% and 26%. However, it might be underestimated if the course of cognitive functions before and after cranioplasty were insufficiently documented.

详细描述

Decompressive craniectomy is a neurosurgical procedure that is used frequently for mass and/or intracranial hypertension. The Trephined Syndrome (or Sinking Skin Flap Syndrome) is a neurological deterioration which follows craniectomy and which is attributed to a large bone flap size. The symptomatology is varied but includes headache, aggravation of a hemisyndrome or cognitive disorders, often has an orthostatic component and improves or disappears with cranioplasty.

The pathophysiology of the Trephined Syndrome is not clearly understood. The hypothesis is that the contents of the skull, which is no longer isolated by the bone, is then subjected to atmospheric pressure, which would lead to changes in the blood flow, but also abnormalities in the circulation of the cerebrospinal fluid and even cell metabolism.

The precise incidence of the Trephined Syndrome is poorly known but is described to be 7% up to 26%. It is much likely underestimated since it concerns patients with preexisting neurological symptoms and often multiple comorbidities. Furthermore its presentation varies in a way, that in certain patients the Trephined Syndrome manifests itself by neurological aggravation, while in other patients it is only the absence of evolution in rehabilitation, followed then by improvement after cranioplasty, which makes it possible to retain this diagnosis a posteriori.

The diagnosis is also difficult since it is a clinical diagnosis of exclusion. The cerebral imaging that shows contralateral herniation than the craniectomy is pathognomonic, but is not a gold standard for diagnosis, since the symptomatology can occur before this stage of radiological presentation.

It is, of course, necessary to wait until the regression of the edema makes it possible to restore the flap without risk of inducing a new lesion but the ideal moment of the cranioplasty is unknown. The risk of infectious disease may be increased during "early" remission, on the other hand the risk of developing the Trephined Syndrome or other complications increases during "late" cranioplasty.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
14 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with decompressive craniectomy for intracranial hypertension secondary to stroke, traumatic brain injury or other non-progressive cerebral pathology.

排除标准

  • patients suffering from a rapidly evolving cerebral pathology (e.g. tumor)
  • patients transferred to other hospitals before cranioplasty or whose follow-up can not be assured.

结局指标

主要结局

Presence of Trephined Syndrome

时间窗: From patients admission to discharge from rehabilitation (approx. 3 months).

To determine the incidence and severity of the the Trephined Syndrome in relation to delay to cranioplasty.

次要结局

  • Complications related to cranioplasty(From patients admission to discharge from rehabilitation (approx. 3 months).)
  • Relation of delay to cranioplasty with neurological outcome(From patients admission to discharge from rehabilitation (approx. 3 months).)
  • Relation of delay to cranioplasty with complications post-cranioplasty(From patients admission to discharge from rehabilitation (approx. 3 months).)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Leemann Beatrice

medical doctor

University Hospital, Geneva

研究点 (1)

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